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Early Prediction of Pathology Response of Chemoradiotherapy With FLT PET

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ClinicalTrials.gov Identifier: NCT01065818
Recruitment Status : Terminated (Lack of funding)
First Posted : February 9, 2010
Results First Posted : September 26, 2017
Last Update Posted : September 26, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

The goal of this research study is to learn if a new type of PET scan (18F-FLT) can help to better detect changes of tumor growth rate (or how active) in esophagus cancer and lung cancer Researchers will study at what time during treatment the 18F-FLT PET scan should be given to get the best results. A Positron Emission Tomography (PET) scan is a type of scan that uses a radioactive solution to locate cancer cells inside the body. Using the PET scan, doctors can locate solid tumors and collect information about how "active" the cancer cells are. For this study, a new type of solution, [F-18]-fluoro-L-thymidine (FLT), will be used. FLT can detect actively growing tumor, and researchers hope that FLT may be able to help provide information about how well esophagus cancer treatment is working. This information could be used to help predict if the cancer will respond to treatment.

All enrolled subjects will receive PET/CT imaging at pre-Neoadjuvant Therapy and post-3 weeks Neoadjuvant Therapy (3 weeks from the start of Neoadjuvant Therapy) prior to the surgery. At each time of the PET/CT procedure, the subject will receive an injection of FLT which is an investigational pharmaceutical labeled with radioactive fluorine. 45-60 mines after the FLT injection, the scan will be performed. Each scan might take 10-15 minutes. Participation in this pilot study will not change the patients normal chemotherapy, radiation treatment, and surgery recommended the patients physician as parts of their standard of care.


Condition or disease Intervention/treatment
Esophageal Cancer Non-small Cell Lung Cancer Drug: Fluoro-L-Thymidine

Detailed Description:
The goal of the study is to obtain preliminary data and initial estimates of the FLT ability-PET to identify pathCR patients who have esophageal carinoma or non-small cell lung cancer and undergo Neoadjuvant Therapy (Chemoradiotherapy, Chemotherapy or Radiation Therapy) prior to surgery. Achievement in pathCR after pre-operative Neoadjuvant Therapy is associated with improved patient outcomes; however, there is no effective method to predict pathological response before surgery. Thus, a patient with pathCR , for whom esophagectomy or thoracoscopy may be unnecessary, still undergoes surgery and faces the prohibitive side effects of this surgical procedure. Additionally, Neoadjuvant Therapy is associated with considerable morbidities and tool to predict and avoid ineffective therapy are lacking. Because deregulated proliferation is one of the hallmarks of cancer and its proliferation rate is associated with aggressive biologic behavior and response to therapy, imaging the proliferative state of cancer cells by non-invasive functional imaging is of great interest. Recently 18F-FLT (3'deoxy33'-18F- fluorothymidine) has been reported as a promising PET radiopharmaceutical for imaging cancer proliferation and has been validated in several in vitro & in vivo models. However, only a few studies addressed its role in depicting changes in cancer proliferation and assessing response to Neoadjuvant Therapy, and none of these studies have focused on esophageal cancer and lung cancer. We propose to conduct a pilot study to learn the optimal FLT PET imaging timepoint during the early course of Neoadjuvant Therapy that has the highest predictive value for pathCR in patients with esophageal cancer or lung cancer.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Early Prediction of Pathology Response of Chemoradiotherapy With FLT PET
Study Start Date : August 2009
Primary Completion Date : February 2013
Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Telbivudine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Fluoro-L-Thymidine
Injection pre-Neoadjuvant Therapy (CRT, CT, or RT) and post-3 weeks Neoadjuvant Therapy (CRT, CT, RT)(3 weeks from the start of Neoadjuvant Therapy) prior to surgery.
Drug: Fluoro-L-Thymidine
4D-PET/CT imaging with an injection of Fluoro-L-Thymidine at pre-Neoadjuvant Therapy and post-3 weeks Neoadjuvant Therapy prior to surgery.
Other Name: FLT


Outcome Measures

Primary Outcome Measures :
  1. Optimal Timepoint During the Course of Neoadjuvant Therapy [CRT, CT (Chemotherapy) or RT Radiotherapy)] That FLT-PET Imaging Can Predict Response [ Time Frame: 2.5 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients with histologically diagnosed adenocarcinoma or squamous cell carcinoma of the esophagus and locoregional disease (stages II and III) and locally advanced non-small cell lung cancer (stage III) will be eligible for participation in this study.

Exclusion Criteria:

  • Abnormal liver function (<2.5 x ULN of aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ; <1.5 x upper limit of normal (ULN) of bilirubin total) or abnormal renal function (<1.5 x ULN of creatinine) or peripheral neuropathy
  • Women with pregnancy or breastfeeding
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01065818


Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
National Cancer Institute (NCI)
Investigators
Principal Investigator: K.S. Clifford Chao, MD Columbia University
More Information

Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT01065818     History of Changes
Other Study ID Numbers: AAAD5444
R21CA121551 ( U.S. NIH Grant/Contract )
First Posted: February 9, 2010    Key Record Dates
Results First Posted: September 26, 2017
Last Update Posted: September 26, 2017
Last Verified: August 2017

Keywords provided by Columbia University:
Esophageal cancer
Non-small cell lung cancer
FLT-PET
Chemoradiotherapy

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Esophageal Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Telbivudine
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action